Recall Z-1104-06 ยท LNH System, Nuclear Magnetic Resonance Imaging
Hitachi Medical Systems America Inc
AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems
| Date | Jun 10, 2006 (initiated Apr 28, 2006) |
| Status | Terminated |
| Reason | Software anomaly-A software defect can cause the slice line indicator to become mis-positioned during Multi-Planar Reconstructions (MPR) with the potential for patient mis-diagnosis. |
| Root cause | Other |
| Action | The firm''s Field Service personnel will apprise the customers of this situation during scheduled visits at each customer location. During this visit, the corrected software will be installed by the Hitachi Field Service Technician. The installation of the software upgrades by the service technicians began on 4/28/2006. The firm anticipates that the correction of all units in their inventory as well as those units installed out-in-the-field will becompleted by 6/15/2006. |
| Quantity | 5 |
| Distribution | The devices were distributed to five (5) customers located in four (4)states: Colorado, Ohio, Nebraska and Texas |
| FDA record | Open on fda.gov |